AstraZeneca has announced that Imfinzi (durvalumab), in combination with standard of care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin and docetaxel), has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for adults with resectable, early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers.
Imfinzi and FLOT form a perioperative regimen that includes neoadjuvant Imfinzi and chemotherapy prior to surgery, adjuvant Imfinzi and chemotherapy, and finally Imfinzi as a monotherapy.
The CHMP’s positive opinion is based on results from the phase 3 MATTERHORN trial. The trial showed that the Imfinzi-FLOT regimen reduced risk of death by 22% compared to chemotherapy alone. Around 69% of Imfinzi-FLOT-treated patients were alive at three years, compared to 62% of patients in the comparator arm of the study.
The safety profile of the combination treatment was consistent with the established safety profiles of each component, and the rate of Grade 3 or higher adverse events was consistent across both arms.
Results from the trial were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine.
Gastric cancer is the fifth highest cause of cancer deaths worldwide, and almost a million people are diagnosed with it each year. There were around 43,000 patients treated for early-stage and locally advanced gastric or GEJ cancer in the US, EU and Japan in 2024.
By 2030, around 62,000 patients across these regions are expected to be newly diagnosed with early-stage and locally advanced gastric or GEJ cancer.
Imfinzi is approved in the US and various other countries for the same indication, with approval following the MATTERHORN data. Additionally, Japan and other countries are currently reviewing regulatory applications for Imfinzi.
Susan Galbraith, executive vice president, oncology haematology R&D at AstraZeneca, said: “The CHMP recommendation marks further progress toward our goal to offer novel approaches in early-stage cancers where there is the greatest chance for cure and brings us closer to providing the third perioperative Imfinzi-based regimen in the EU.”